Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
This study has been completed.
Sponsor:
The Cleveland Clinic
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00231218
First received: September 30, 2005
Last updated: December 13, 2006
Last verified: December 2006
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 30, 2005 | ||||
| Last Updated Date | December 13, 2006 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
upper respiratory tract infections | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00231218 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
gastroenteritis | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers | ||||
| Official Title ICMJE | the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study | ||||
| Brief Summary | We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group. |
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| Detailed Description | This combination of herbs has been studied only once before in preschoolers. In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138). We are repeating this study to see if our results confirm or contradict those of the previous study. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: dietary supplement--echinacea, propolis, and vitamin c | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 104 | ||||
| Completion Date | March 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 6 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00231218 | ||||
| Other Study ID Numbers ICMJE | 8348 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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